drugset / Trial / NCT04465383

Digital Sedation: Virtual Reality Hypnosis During Colonoscopy

NCT04465383 ↗

RandomizedParallel-groupOpen-labelSupportive care

Summary

This prospective Randomized Controlled Trial will evaluate efficacy, safety, and pharmacoeconomic outcomes in patients undergoing colonoscopy with either Digital Sedation using the Aqua© module of the Oncomfort device (Sedakit TM) or the standard of care, intravenous sedation with propofol. The Aqua© module is designed for sedation and management of pain and anxiety related to medical and surgical procedures.

Timeline

Start
2020-06-25
Primary completion
2021-09-20
Completion
2021-12-21

Outcome

Outcome not reported

Stopped (Enrollment): “Recruitment too complicated during pandemics. Phase 2 of recruitment completed and enough data available.”

Drugs

EvaluationDrugModalityDoseRoute
Subject Propofol Small molecule 1 ug/ml Intravenous
Subject Propofol Small molecule 6 ug/ml Intravenous

Indications

No indication recorded.